Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04326127




Registration number
NCT04326127
Ethics application status
Date submitted
26/03/2020
Date registered
30/03/2020
Date last updated
31/03/2020

Titles & IDs
Public title
Evaluation of Compumedics "Somfit" Device
Scientific title
Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device
Secondary ID [1] 0 0
SOMFIT02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

Control - Healthy volunteers

Case - Volunteers with diagnosed sleep apnea


Treatment: Devices: Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
Data were recorded overnight by both devices simultaneously
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison between raw EEG signals
Timepoint [1] 0 0
single night recording for each subject
Secondary outcome [1] 0 0
Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram
Timepoint [1] 0 0
single night recording for each subject

Eligibility
Key inclusion criteria
* Individuals age between 18 to 75
* Be able to give informed consent
* Individuals with diagnosed Obstructive Sleep Apnoea (OSA)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Less than 18 years of age
* Greater than 75 years of age
* Unable or not willing to provide informed consent
* Need for nursing care
* Currently working nightshift

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2019
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
SleepMetrics Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3752 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Compumedics Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Kealy
Address 0 0
Sleepmetrics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04326127